Br J Obstet Gynaecol. 1993 Jun;100(6):516-23. doi: 10.1111/j.1471-0528.1993.tb15300.x.
To assess whether cervical cerclage in women deemed to be at increased risk of cervical incompetence prolongs pregnancy and thereby improves fetal and neonatal outcome.
Multicentre randomised controlled trial.
Hospitals in the United Kingdom, France, Hungary, Norway, Italy, Belgium, Zimbabwe, South Africa, Iceland, Ireland, the Netherlands and Canada.
One thousand two hundred and ninety-two pregnant women whose obstetricians were uncertain whether to recommend cervical cerclage, most of whom had a history of early delivery or cervical surgery.
Cervical cerclage was compared with a policy of withholding the operation unless it was considered to be clearly indicated.
Delivery before 33 completed weeks, preterm delivery (< 37 weeks), and vital status of the baby after completion of the pregnancy.
The overall preterm delivery rate was 28%. There were fewer deliveries before 33 weeks in the cerclage group (83 (13%) compared with 110 (17%), P = 0.03) and this difference reflected deliveries characterised by features of cervical incompetence (painless cervical dilatation and prelabour rupture of the membranes). There was a corresponding difference in very low birthweight deliveries (63 (10%) compared with 86 (13%), P = 0.05). The difference in the overall rate of miscarriage, stillbirth or neonatal death (55 (9%) compared with 68 (11%)) was less marked and was not statistically significant. The use of cervical cerclage was associated with increased medical intervention and a doubling of the risk of puerperal pyrexia.
These results suggest that the operation had an important beneficial effect in 1 in 25 cases in the trial (95% confidence interval (CI) 1 in 12 to 1 in 300 sutures). Its use is associated with increased medical intervention and puerperal pyrexia. Nevertheless, this trial suggests that, on balance, cervical cerclage should be offered to women at high risk, such as those with a history of three or more pregnancies ending before 37 weeks gestation.
评估对于被认为宫颈机能不全风险增加的女性，宫颈环扎术是否能延长孕周，从而改善胎儿及新生儿结局。
多中心随机对照试验。
英国、法国、匈牙利、挪威、意大利、比利时、津巴布韦、南非、冰岛、爱尔兰、荷兰及加拿大的医院。
1292名孕妇，其产科医生不确定是否应建议行宫颈环扎术，其中大多数有早产或宫颈手术史。
将宫颈环扎术与除非明确有指征否则不行手术的策略进行比较。
孕33周前分娩、早产（<37周）以及妊娠结束后婴儿的生命状态。
总体早产率为28%。环扎组孕33周前分娩的情况较少（83例（13%），而未环扎组为110例（17%），P = 0.03），这种差异反映在以宫颈机能不全特征（无痛性宫颈扩张和胎膜早破）为特点的分娩中。极低出生体重儿分娩也有相应差异（63例（10%），而未环扎组为86例（13%），P = 0.05）。流产、死产或新生儿死亡的总体发生率差异较小（55例（9%），而未环扎组为68例（11%）），且无统计学意义。宫颈环扎术的使用与更多的医疗干预相关，产褥期发热风险增加一倍。
这些结果表明，在该试验中，该手术在每25例中有1例产生重要有益效果（95%置信区间为每12例中有1例至每300例缝合中有1例）。其使用与更多医疗干预和产褥期发热相关。然而，该试验表明，总体而言，对于高危女性，如那些有三次或更多次妊娠在孕37周前结束病史的女性，应提供宫颈环扎术。
